MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-13 for I-STAT ACT CELITE CARTRIDGE 03P86-25 manufactured by Abbott Point Of Care.
[45199592]
Apoc incident # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45199593]
On (b)(6) 2016, abbott point of care (apoc) was contacted by a customer regarding act celite cartridges that yielded unexpected results on a patient associated with lot# r16004. The customer states that the physician gave heparin as act was low and the patient developed a bleed in the eye and wrist. Patient was re-assessed and there are no apparent signs of progression. The patient's current state of condition is unknown at this time. There was no additional patient information at the time of this report. The facility states that samples for i-stat were drawn after heparin was administered. The facility also states that return product is not available for investigation. Sample time: 1743, test time: 1743, i-stat result: 193, sample type: arterial, heparin time: 1743, heparin doses: 5000 units, comments: no baseline testing performed; 1811, 1811, 202, arterial, 1811, 4000 units, na; 1830, 1830, 193, arterial, 1830, 4000 units, no testing performed between 1830 & 1954 hrs; 1954, 1954, >1000, venous, na, na, result was very high after heparin received; 2025, 2025, 679, venous, na, na, na; 2108, 2108, 229, venous, na, na, na. There are no injuries associated with this event. Customer states the patient was discharged the next day after the procedure. However, apoc has determined that an adverse event has occured in that the patient developed bleeding in the eye and wrist based on the amount of heparin administered during the procedure. The customer states that no act testing was performed from 18:30 and 19:54 during the interventional and diagnostic procedure at the facility. At this time and based on the information available there is no reason to suspect a malfunction exits. Nor is there reason to believe that apoc product caused or contributed to the event. Preliminary investigation on retains testing shows that product is performing to specification. The full investigation is pending.
Patient Sequence No: 1, Text Type: D, B5
[46133057]
(b)(4). The investigation was completed on 05/16/2015. Retain product was tested and is functioning according to specification. Return product was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
[46133058]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2016-00028 |
| MDR Report Key | 5652747 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-13 |
| Date Mfgr Received | 2016-05-16 |
| Device Manufacturer Date | 2016-01-04 |
| Date Added to Maude | 2016-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA MACZUSZENKO |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6136885949 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 185 CORKSTOWN ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2H 8V4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K2H 8V4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT ACT CELITE CARTRIDGE |
| Generic Name | ACT CELITE CARTRIDGE |
| Product Code | JBP |
| Date Received | 2016-05-13 |
| Model Number | NA |
| Catalog Number | 03P86-25 |
| Lot Number | R16004 |
| Device Expiration Date | 2016-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-13 |