MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-01 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[3080137]
Epicel heat sealer deviation, graft dishes leakage [device malfunction]. A (b)(6) female, initials (b)(6), with 90% burns, received epicel (lot ee01624) cea graft on (b)(6) 2012. At the surgical procedure site, it was observed that the epicel transport unit with 40 grafts contained transport media which was concluded to have leaked from the graft dishes. According to the mfr medical science liaison, all the epicel grafts looked fine at time of procedure. There were no visible signs of epicel graft deterioration or contamination. The decision was made that the grafts were fit for use. The percent take for all applied pt epicel grafts was described as 80%, which is within statistical norm. At the time of this report, the pt is doing very well with excellent graft uptake. Potential serious risks to patient were identified as cell viability (potential graft failure) and sterility (potential breach). Description of the critical deviation: epicel grafts are packaged in polystyrene dishes in sterile transport media (dmem). The dishes are heat sealed with a foil lid. The foil lid is heat sealed in place using a heat sealing apparatus. Recently the epicel transport dishes were approved for a new foil lid. (s12 (b)(6) 2012). The epicel dishes are placed in a transport unit (metal container) and hand carried to the treatment site. On (b)(6) 2012, a product complaint was received by our internal customer service department via email from the genzyme medical science liaison (msl) present at the surgery for epicel patient lot ee01624. Upon receipt of the grafts, the msl observed approximately 20mls of transport media in the transport unit. The msl concluded that some of the graft dishes must have leaked, however, he could not identify which graft dishes the media had come from or how many of the dishes had leaked. During the grafting procedure it was noted by the msl that the surgeon felt the foil lid was easier than usual to peel off. The new foil lid should require more effort to remove than the previous foil lid. Catsweb record (b)(4) indicates from the msl that all 40 grafts received were used during the surgery for patient (b)(6). During batch record review for patient (b)(6) no deviations were noted. However, as part of the complaint investigation, it was noted by mfg management on (b)(4) 2012 that the heat sealer used during the subsequent epicel grafting for epicel patient lot ee01624 on (b)(6) 2012 was not operating as intended. Five out of forty-nine grafts were sealed using the unit in question for lot ee01612. The five grafts passed qc inspection prior to release. This was the same heat sealer used in the preparation of the grafts for patient lot ee01624. The malfunctioning heat sealer was removed from service. A second heat sealer was used to complete the mfr of the remaining 44 grafts for patient ee01612. All grafts passed qc inspection and all grafts shipped were utilized during surgery for patient (b)(6). There were no associated with this patient's graft. On (b)(6) 2012 a deviation dr# (b)(4), was initiated for heat sealer id number: (b)(4) for not operating as expected during the grafting of epicel patient lot ee01612.
Patient Sequence No: 1, Text Type: D, B5
[10267582]
Conclusion: biosurgery conducted a robust in depth deviation investigation into this event. The root cause was determined and multiple corrective actions were identified. A review for previous occurrences of a malfunctioning heat sealer indicated that this was the first occurrence of this type of event and no trend was identified. Based on the findings there were no further actions required other than the capas that have been initiated. Mfr? S comment: the benefit-risk profile of the product is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2012-00007 |
| MDR Report Key | 2835216 |
| Report Source | 05,07 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-08-14 |
| Date Mfgr Received | 2012-10-12 |
| Date Added to Maude | 2013-02-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | GENZYME BIOSURGERY |
| Manufacturer Street | 64 SIDNEY ST. |
| Manufacturer City | CAMBRIDGE MA 02139413 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02139 4136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2012-11-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01624 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Address | 64 SIDNEY ST. CAMBRIDGE MA 02139413 US 02139 4136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-01 |