MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-23 for ESP 80A AEROBIC BROTH 7101-44 manufactured by Accumed Intl., Inc..
[20883632]
The following info was provided by the attending neonatologist and other hosp personnel: a premature infant (30-31 weeks gestation) was delivered by caesarian on 08/29/98. During the efforts to resuscitate the infant, a physician requested an injection of albumin. However, instead of albumin, 5-10 cc of an in vitro diagnostic product intended for detection of septicemia was injected instead. The infant died one day later on 08/30/98. The attending neonatologist stated that he did not believe that the injection error was the cause of death since the infant had significant other medical problems including early delivery, fetal to maternal hemorrhaging, and pulmonary hypotension. As of 09/22/98, the medical examiner was still evaluating the case. The product that was injected by mistake was a microbiological culture medium intended for the detection of septicemia. It is labeled as an in vitro diagnostic product and is not intended for any other use. Based on all info to date, there is no evidence that the product caused or contributed to the infant's death and it is clear that the product was used in a manner for which it was never intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939828-1998-00001 |
| MDR Report Key | 188487 |
| Report Source | 05 |
| Date Received | 1998-09-23 |
| Date of Event | 1998-08-29 |
| Date Mfgr Received | 1998-08-29 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1998-09-24 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESP 80A AEROBIC BROTH |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | JSS |
| Date Received | 1998-09-23 |
| Model Number | NA |
| Catalog Number | 7101-44 |
| Lot Number | 127631SA |
| ID Number | * |
| Device Expiration Date | 1999-10-31 |
| 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 | 183178 |
| Manufacturer | ACCUMED INTL., INC. |
| Manufacturer Address | 920 NORTH FRANKLIN, SUITE 402 CHICAGO IL 60610 US |
| Baseline Brand Name | ESP 80A AEROBIC BROTH |
| Baseline Generic Name | IN VITRO DIAGNOSTIC |
| Baseline Model No | NA |
| Baseline Catalog No | 7101-44 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening | 1998-09-23 |