MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-28 for ARTERIELLER FILTER QUART BO-HBF 140-J 701048784 manufactured by Maquet Cardiopulmonary Ag.
[68833655]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[68833656]
During priming, it was noted that the priming solution was leaking from the side of the quart. The leakage was occurring at low pressure at the beginning of priming. The customer stopped using the device. It occurred before patient use. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[69250085]
Maquet cardiopulmonary (b)(4) is aware of similar complaints from this product. Similar products, showing a similar malfunction. Maquet cardiopulmonary (b)(4) received the product back for manufacturer investigation. During laboratory investigation a tightness test was performed. There by leakage between housing and cover has been detected at the quart filter. Therefore the reported leakage could be confirmed. The failure is already known to the manufacturer and has been thoroughly investigated. The most possible root cause is the bad bonding between housing and the cover of the quart filter. Based on this no further action will be completed at this time. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further investigation initiations will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[69250086]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2017-00061 |
| MDR Report Key | 6364042 |
| Date Received | 2017-02-28 |
| Date of Report | 2017-03-06 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-02-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | BERND RAKOW |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTERIELLER FILTER QUART |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2017-02-28 |
| Model Number | BO-HBF 140-J |
| Catalog Number | 701048784 |
| Lot Number | 70104274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-28 |