MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-06-18 for PALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE CPS02NS manufactured by Pall Life Sciences Puerto Rico, Llc.
[870371]
It was reported that during assembly of the device into tubing at a tubing pack manufacturer, a yellow particle was seen in the downstream housing.
Patient Sequence No: 1, Text Type: D, B5
[8107055]
The returned device was evaluated at its manufacturing facility. A review of the device history file was not possible because the user did not report the lot number. Visual inspection confirmed the reported deviation. The device returned included one yellow movable particle inside the filter outlet housing. Using a size examination chart, the surface area was approximately 3. 00 square millimeters. This particle appeared to be a fragment of the device's end cap material. This type of particle may be generated during the manufacturing process of end capping. A visual inspection procedure occurs following end capping, and includes particulates as part of the inspectional targets. It is possible that the inspector could not see the particle because of its position in the device, or that the inspector failed to perceive a visible particle. Summary: the user's report was confirmed. The proximate cause appeared to be manufacturing operator error in not detecting the deviation. The root cause could not be identified. It is noted that a general particulate reduction plan was implemented in revision in march of 2008. Unless substantially significant information becomes available, this constitutes a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647898-2008-00002 |
| MDR Report Key | 1060686 |
| Report Source | 05,06,07 |
| Date Received | 2008-06-18 |
| Date of Report | 2008-05-27 |
| Date of Event | 2008-05-13 |
| Report Date | 2008-05-27 |
| Date Reported to Mfgr | 2008-05-27 |
| Date Mfgr Received | 2008-05-27 |
| Date Added to Maude | 2010-04-08 |
| 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 | DR. LEONARD BERMAN |
| Manufacturer Street | 25 HARBOR PARK DR |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5168019183 |
| Manufacturer G1 | PALL LIFE SCIENCES PUERTO RICO, LLC |
| Manufacturer Street | PALL BLVD. 98 |
| Manufacturer City | FAJARDO PR 00738 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00738 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE |
| Generic Name | 0.2 MICRON CARDIOPLEGIA FILTER |
| Product Code | JOD |
| Date Received | 2008-06-18 |
| Returned To Mfg | 2008-05-29 |
| Model Number | CPS02NS |
| Lot Number | UNK |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL LIFE SCIENCES PUERTO RICO, LLC |
| Manufacturer Address | PALL BLVD. 98 FAJARDO PR 00738 US 00738 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-18 |