MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-22 for IMUFLEX DISPOSABLES 1BBLGQ506A6 manufactured by Terumo Corporation/terumo Bct.
[3591522]
The customer reported that blood passed the one way valve, bypassing the filter, during filtration of the whole blood unit. The product was discarded. There was not a transfusion recipient or patient involved at the time of the whole blood processing for plasma units, therefore, no patient information is reasonably known at the time of the event. (b)(6). This report is being filed due to a device malfunction that has the potential for injury.
Patient Sequence No: 1, Text Type: D, B5
[11020490]
(b)(4). Investigation: a whole blood bag, red blood cell bag, and filter were received for evaluation. White blood cell contamination of the blood in the filtered blood bag was observed. Investigation evaluation and corrective actions are in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[34320066]
The disposable set was received for investigation. A sample of blood was taken from the filtered bag and measured for the level of white blood cells present. The level was found to be higher than the level of white blood cells which were filtered normally. A filtering test was conducted on the return sample and it was confirmed that the blood had passed the one-way valve. The one-way valve was disassembled to observe the slit of the valve. It was found that the slit was not in the correct position according to specifications. Reserve samples for this lot were tested for the same filtering issue. No similar issues were noted with these samples. The manufacturing and testing records were reviewed. The lot conformed to all specifications. A request for the valve assembly supplier manufacturer records showed that a blade used to make the slits had become unstable and it had affected some lots including this one. The supplier responded that there was a possibility that the valves with the improper slit could have been overlooked, during visual quality checks. Root cause: the root cause of the incident in question was the incorrect position of the valve slit. Consequently, the blood flowed backwards caused by pressure of the blood in the donation bag during filtration. Corrective action:1. The valve assembly supplier adjusted the mechanism for slitting. 2. The valve assembly supplier has implemented 100% inspection of the valve slits.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2013-01360 |
| MDR Report Key | 3304042 |
| Report Source | 05 |
| Date Received | 2013-08-22 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-07-12 |
| Date Mfgr Received | 2013-09-18 |
| Date Added to Maude | 2013-11-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN COHEN |
| Manufacturer Street | 10811 W COLLINS AVENUE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMUFLEX DISPOSABLES |
| Generic Name | IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LEUKOCYTE REDUCTIO |
| Product Code | KSR |
| Date Received | 2013-08-22 |
| Returned To Mfg | 2013-07-25 |
| Catalog Number | 1BBLGQ506A6 |
| Lot Number | 121130AF |
| Device Expiration Date | 2014-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION/TERUMO BCT |
| Manufacturer Address | FUJINOMIYA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-22 |