MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for CAPIOX ARTERIAL FILTER ZZ*AF02 manufactured by Terumo Corporation, Ashitaka.
[90703908]
Udi number for this product code is not required. The actual device has been returned to the manufacturing facility for evaluation. The account used a terumo (b)(4) made tubing pack with this device. Prior to being sent to the ashitaka facility terumo (b)(4) performed blood pathway testing. Leaking occurred on both the inlet and outlet during blood pathway testing with water at 0. 6 bar, 1/4 x 1/16 tubing was attached and cable tied to the device. Once the actual device was received at the ashitaka facility it was visual inspected. No anomalies which would relate to the reported leaks, in the appearance was noted. Magnifying inspection of the inlet port and outlet port did not reveal any anomalies. Each port was connected to a 1/4" tube and the blood pathway was filled with saline solution. With the blood outlet port side clamped, the blood pathway was pressurized at an air of 1. 6 kgf/cm2 while the actual device was being observed for any leakage. No leak was confirmed. A review of the device history record and product release decision control sheet from the reported product code/lot number combination was conducted with no relevant findings. A search of the complaint file found one other report with the involved product/lot# combination. Refer to mdr 9681834-2017-00229. There is no evidence that this event was related to a device defect or malfunction. The investigation result verified the actual sample was normal products with no leak at any joints. The exact cause of the reported event cannot be definitively determined based on the available information. (b)(4). All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Patient Sequence No: 1, Text Type: N, H10
[90703909]
The user facility reported a leak in the capiox device after a procedure. Follow up communication with the user facility confirmed the following information: during rewarming a few drops of blood leaked from the arterial filter port; extra ties straps were put on the arterial filter connection to stop the leaking; the procedure was completed successfully; and there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681834-2017-00222 |
| MDR Report Key | 6960695 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2016-11-02 |
| Date Added to Maude | 2017-10-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | REG. NO. 2243441 2101 COTTONTAIL LN. |
| Manufacturer City | SOMERSET NJ 08873 |
| Manufacturer Country | US |
| Manufacturer Postal | 08873 |
| 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 | 0 |
| Brand Name | CAPIOX ARTERIAL FILTER |
| Generic Name | CAPIOX ARTERIAL FILTER |
| Product Code | DTM |
| Date Received | 2017-10-19 |
| Returned To Mfg | 2017-09-29 |
| Model Number | NA |
| Catalog Number | ZZ*AF02 |
| Lot Number | 161102 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2017-10-19 |