MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-10 for CAPIOX ARTERIAL FILTER CX-XR367M01 manufactured by Terumo Corporation, Ashitaka.
[123275218]
Udi - not required for this product code. Implanted date: device was not implanted. Explanted date: device was not explanted. The 510k - k943917. The actual device was received for evaluation. Visual inspection revealed a crack had been generated on the blood inlet port. Saline solution was let to flow through the actual device. The saline solution leaked at the crack. The outside and inside diameters of the blood inlet port were measured at a point adjacent to the crack. They were confirmed to be comparable to those of the current product sample. A factory-retained sample of the involved product code was hit on the blood inlet port with a hammer. The blood inlet port was exposed to intensive shock force, resulting in the generation of a crack which was similar to that observed on the actual sample. A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings. Ifu states: do not add excessive shock to the filter, such as tapping with forceps, during priming or bypass, as this could damage the product. There is no evidence that this event was related to a device defect or malfunction. Based on the investigation, it is likely that the actual device was subjected to shock force on the blood inlet port and got cracked, resulting in the reported leak of the priming solution. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123275219]
The user facility reported that pre-treatment after the capiox custom pack circuit was set on the hlm; during priming, when the customer hit the actual sample with a hammer, the prime started to leak. It was found that the actual sample found a crack on the blood inlet port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681834-2018-00180 |
| MDR Report Key | 7952572 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2018-07-20 |
| Date Added to Maude | 2018-10-10 |
| 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 | MARK VORNHEDER |
| Manufacturer Street | REG. NO. 2243441 950 ELKTON BLVD |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Street | REG. NO. 9681834 150 MAIMAIGI-CHO |
| Manufacturer City | FUJINOMIYA CITY, SHIZUOKA 418 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 418 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIOX ARTERIAL FILTER |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-10-10 |
| Returned To Mfg | 2018-09-21 |
| Model Number | NA |
| Catalog Number | CX-XR367M01 |
| Lot Number | 180720 |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Address | 150 MAIMAIGI-CHO FUJINOMIYA CITY, SHIZUOKA 418 JA 418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-10 |