MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-05 for I-STAT ACT CELITE CARTRIDGE 03P86-25 manufactured by Abbott Point Of Care.
[27692211]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27692212]
On (b)(6) 2015, abbott point of care was contacted by a customer regarding act kaolin cartridge that yielded unexpected results on a (b)(6) year old male patient with coronary artery disease undergoing cardiac stent procedure in the cath lab. The customer states that angiomax was used but there was no testing on the i-stat system during this time and the procedure completed 11:12. Additional catheterization was performed using heparin. Act measured on i-stat. During recovery, patient coded, was intubated and returned to the cath lab. The customer is returning product for investigation. (b)(6). The patient developed severe nose bleed. Ear, nose and throat specialist was brought in to packed the nose and stop the bleeding. The nurse indicated the nose bleed can be a complication of intubation. The patient was admitted. Patient remains inpatient and is stable. There are no injuries associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[31797259]
Apoc incident # (b)(4). The investigation was completed on 11/12/2015. Customer returns and retain product was tested and are functioning according to specification.
Patient Sequence No: 1, Text Type: N, H10
[31797260]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2015-00052 |
| MDR Report Key | 5127025 |
| Date Received | 2015-10-05 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-09-14 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2015-05-08 |
| Date Added to Maude | 2015-10-05 |
| 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 | 2015-10-05 |
| Returned To Mfg | 2015-10-10 |
| Model Number | NA |
| Catalog Number | 03P86-25 |
| Lot Number | T15128 |
| Device Expiration Date | 2015-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-10-05 |