MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for PENGUIN THERMA-LINER manufactured by Ameda, Inc..
[69167952]
Com-pac received 10 therma-liner bags from ameda, inc. (customer) and verified that there were small holes in the walls of the inner bags. There was no leakage from one of three bags received from memorial hermann health. Com-pac reviewed qa inspection logs for the manufacturer dates indicated and determined there were no rejected units for leakage. Ameda, inc. Randomly selected a carton of 50 units from their inventory and randomly selected 10 units from that carton. The bag's water compartment was filled with water and leaned vertically against the wall. Moisture was observed under one of the ten bags the next morning. Location of leak was not verified. Ameda, inc. Sent 50 bags to com-pac for testing. Com-pac conducted inverted water leak testing and internal (vacuum) pressure on all 50 returned bags. Water compartment bags were filled with 6 oz water and hung such that water impinged on each of 2 side seals, the bottom fold and zipper for 30 minutes. No water leakage was indicated. Absorbent media which was placed into inner bag compartment indicated no internal leakage. The bag which ameda indicated leaked showed no evidence of leakage during com-pac testing.
Patient Sequence No: 1, Text Type: N, H10
[69167953]
(b)(6), risk manager at (b)(6) submitted a sus voluntary event report to the fda on 12/29/2016 and was recovered by the fda on 01/04/2017. (mw5067021) submission of the medwatch was for the issue of leaking water from the external jacket into the dry internal compartment that houses the breast milk feeding container of the therma-liner bags used in the ameda penguin nutritional warmer system. If this event occurs, the internal compartment is compromised which can result in potential contamination of the babie's food source. There were no babies harmed due to the leaking therma-liners. The ameda sales representative for this region consulted with the nicu manager at (b)(6) on 02/02/2017 after ameda was notified of this mw submission by the fda. Leaking therma-liner bags were obtained from this facility and overnight shipped to ameda, inc. For further investigation by ameda and com-pac, the manufacturer of therma-liner bags for the penguin nutritional warmer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009974348-2017-00255 |
| MDR Report Key | 6372132 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-02-01 |
| Device Manufacturer Date | 2016-10-20 |
| Date Added to Maude | 2017-03-02 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDA ZAGER |
| Manufacturer Street | 485 HALF DAY RD. SUITE 320 |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8479642620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PENGUIN THERMA-LINER |
| Generic Name | THERMA-LINER |
| Product Code | FPF |
| Date Received | 2017-03-02 |
| Returned To Mfg | 2017-02-03 |
| Lot Number | C220106 C124106 |
| Operator | NURSE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDA, INC. |
| Manufacturer Address | 485 HALF DAY RD. SUITE 320 BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-02 |