MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1998-04-01 for AN-69 FIL-20 manufactured by Gambro Healthcare.
[95917]
External blood leak from a crack in the arterial cap of the dialyzer. No rinseback done. No pt injury or intervention. Dialyzer changed and treatment resumed.
Patient Sequence No: 1, Text Type: D, B5
[7766244]
Investigation/determination of cause it is also important to note that some chemical solvents or substances may induce blood header cracks. This is emphasized in the instructions for use where it is specified that "the following products are especially forbidden: halogenated aromatic and aliphatic solvents, ketonic solvents. Twelve samples were returned for investigation and were inspected by the manufacturers lab. No blood header cracks were observed. This incident is considered to be a random occurrence. Follow-up action: the mfr has implemented the following corrective actions: 1) improvement of the welding conditions beginning with lot 98c1767. 2) restriction of the use of the potting caps used during the potting process since these mfg accessories may induce the presence of traces of polyurethane beginning with lot 98c2376. 3) specific maintenance operations on the potting equipment that was launched at the end of 3/1998. This lot was produced prior to the above corrective actions being done.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010182-1998-00001 |
| MDR Report Key | 160479 |
| Report Source | 06,07 |
| Date Received | 1998-04-01 |
| Date of Report | 1998-04-01 |
| Date of Event | 1998-03-02 |
| Date Mfgr Received | 1998-03-02 |
| Date Added to Maude | 1998-04-03 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AN-69 |
| Generic Name | FILTRAL 20 |
| Product Code | FJG |
| Date Received | 1998-04-01 |
| Model Number | FIL-20 |
| Catalog Number | FIL-20 |
| Lot Number | 97B2879 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 156281 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK STREET LAKEWOOD CO 80215 US |
| Baseline Brand Name | AN69 HOLLOW FIBER DIALYZER |
| Baseline Generic Name | CAVH/D HEMOFILTRATION |
| Baseline Model No | NA |
| Baseline Catalog No | FIL-20 |
| Baseline ID | NA |
| Baseline Device Family | HEMOFILTRATION |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901368 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-01 |