MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for PALL MEDICAL 791-03 manufactured by Pall Corporation.
[42770205]
(b)(4) laboratory technologists performed a cell wash procedure for an unrelated allogeneic hpc, cord blood unit on (b)(6) 2016 in preparation for distribution of the washed product for infusion into a recipient at (b)(6). After completing centrifugation of the product as required by the wash protocol, the technologists removed the centrifuge bucket from the centrifuge. Upon visually inspecting the cell wash/infusion bag of the wash set residing in the centrifuge bucket support insert, it was determined that fluid had leaked from the cell wash/infusion bag and was being contained in the support insert. (b)(4) laboratory technologists immediately notified the quality management supervisor and quality coordinator of the findings. The quality management supervisor and quality control coordinator went to the clean room facility to assist in assessing the incident. Visual examination of the cell wash/infusion bag revealed a very small pin hole at the base of the cell wash/infusion bag above the heat seal. On visual inspection, it does not appear that the heat seal is involved. As a result of the pin hole, approx 5ml of the product with a tnc of 2. 17 x 10. 7 was lost. Measures were initiated for cellular product rescue and wash of the remaining product using dextran was completed. Cellular product rescue resulted in a tnc recovery of 93 x 10. 7 resulting in a tnc cell dose for infusion of 11. 63 x 10. 7/kg. As a result of the cell wash/infusion bag integrity failure, the sterility of the unit was compromised. After review of the findings and due to the medical necessity, it was determined by the patient's transplant physician to infuse the product. The product was infused on (b)(6) 3016 without incident. Sterility testing results are pending as of the date of this report 04/06/2016.
Patient Sequence No: 1, Text Type: D, B5
[54916031]
Add'l info received on july 18, 2016 for report mw5061646. On (b)(6) 2016, bmt lab technologist performed a cell wash procedure for an unrelated allogeneic hpc, cord blood unit for infusion into the designated recipient. A cell wash/infusion set integrity failure occurred during centrifugation and was reported to pall medical on (b)(6) 2016. Voluntary medwatch report (#(b)(4)) was submitted. In this incident, a very small pin hole was noted at the base of the bag compromising the sterility of the product. The cord blood unit (cbu) failed to engraft. A second cbu was requested for wash and infusion into the same pt. On (b)(6) 2016, bmt lab technologists performed the cell wash procedure for the second unrelated allogeneic hpc, cord blood unit in preparation for infusion into the designated recipient. After completing the centrifugation of the product, the technologists removed the centrifuge bucket from the centrifuge, and observed that an integrity failure of the cell wash/infusion set had occurred a second time. Visual examination of the cell wash/infusion bag for this incident revealed the majority of the seal at the bottom of the bag had failed. The product emptied from the bag but remained contained to the centrifuge bucket support insert for product recovery. An internal investigation was initiated to assess the findings of this incident. The current mfr's product insert for the cell wash/infusion set 791-03 was obtained from (b)(4) to verify the acceptable maximum recommended fill volumes for each bag as well as the recommended centrifuge speed. The product insert indicates a maximum recommended fill volume for each bag of 250ml and further indicates not to centrifuge at more than 1500g for 30 minutes. The product volume washed and centrifuge speed used for the cell wash procedure was far below the mfr's recommendations. Centrifugation and testing of mock cell wash/infusion sets filled to a volume similar to that of the pt product and centrifuged at 880g yielded similar results in which the seal at the base of the bag failed for sets tested. The physical integrity of 7 our of 8 mock cell wash/infusion sets tested and centrifuged at 400g remained in tact. A single integrity failure observed at 400g resulted in a small pin hole occurring at the bottom seal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061646 |
| MDR Report Key | 5573349 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-03-30 |
| Date Added to Maude | 2016-04-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL MEDICAL |
| Generic Name | CELL WASH/INFUSION SET |
| Product Code | KSR |
| Date Received | 2016-04-11 |
| Returned To Mfg | 2016-06-15 |
| Catalog Number | 791-03 |
| Lot Number | 1553126 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PALL CORPORATION |
| Manufacturer Address | 25 HARBOR PARK DR. PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-11 |