MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-03-05 for BERLIN HEART EXCOR DRIVING TUBE L20H-002X01 manufactured by Berlin Heart Gmbh.
[4463824]
We were informed that the hospital replaced a red excor driving tube because of a leakage of the tube. When the incident occurred the pt was supported with the excor stationary driving unit ikus. We were informed that there were no complications regarding the leakage of the excor driving tube or after the replacement. The pt is still supported with the excor system.
Patient Sequence No: 1, Text Type: D, B5
[11855216]
Exemption number: (b)(4). (b)(4) is submitting the report on behalf of berlin heart (b)(4) (mfr). The excor driving tube lot 00002867 was in use from (b)(6) 2012 until its replacement (date unk). The distributor returned it to the mfr without explanation on (b)(6) 2013. Multiple phone calls from (b)(6) 2013 to the distributor determined the drive line was returned to the distributor with a complaint of an air leak. In the investigation a leak in the passage from thinner to thicker diameter was detected. It was reported that the pt was very active. Therefore it is very likely that the leakage was caused by external forces during the time of usage. In the end it is not possible to find definitely the origin of the initial damage. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004582654-2013-00004 |
| MDR Report Key | 3755439 |
| Report Source | 08 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-03-05 |
| Date Facility Aware | 2013-02-08 |
| Date Mfgr Received | 2013-02-05 |
| Device Manufacturer Date | 2011-03-29 |
| Date Added to Maude | 2014-04-17 |
| 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 | DAVID JONES |
| Manufacturer Street | 200 VALLEYWOOD RD. SUITE A500 |
| Manufacturer City | THE WOODLANDS TX 77380 |
| Manufacturer Country | US |
| Manufacturer Postal | 77380 |
| Manufacturer Phone | 2818639700 |
| Manufacturer G1 | BERLIN HEART GMBH |
| Manufacturer Street | WIESENWEG 10 |
| Manufacturer City | BERLIN 12247 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 12247 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERLIN HEART EXCOR DRIVING TUBE |
| Generic Name | DRIVING TUBE RED 6/8 MM |
| Product Code | PCK |
| Date Received | 2013-03-05 |
| Returned To Mfg | 2013-01-28 |
| Model Number | L20H-002X01 |
| Catalog Number | L20H-002X01 |
| Lot Number | 00002867 |
| Device Expiration Date | 2014-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 338 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERLIN HEART GMBH |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-05 |